Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)

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Fudan University

Status

Unknown

Conditions

Angioplasty, Balloon, Coronary
Coronary Occlusion

Treatments

Procedure: percutaneous coronary intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03522038
ZS-CV-201801

Details and patient eligibility

About

The aim of this study is to investigate the role of functional evaluation for predicting clinical outcome in patients with coronary chronic total occlusion (CTO) undergoing percutaneous coronary intervention (PCI), and to evaluate the clinical evidence for the using of fractional flow reserve (FFR), coronary flow reserve (CFR), index of myocardial resistance (IMR) and dynamic single photon emission computed tomography (D-SPECT) in these patients.

Full description

PCI for CTO has dramatically changed in recent years. Although, with the improvement of devices and refinement of operator techniques, PCI of CTO can currently be performed with high success and low complication rates at experienced centers, the clinical benefit of recanalization of CTO is still a matter of debate. Accumulating evidence suggests that the improvement of left ventricular functional and prognosis is closely related with the area of viable myocardium, which has the potential for contractile recovery after revascularization. For the majority of interventional cardiologists, coronary angiography is the only invasive test deemed necessary for clinical decision-making, despite its weak ability to predict the functional impact of vascular occlusion on the subtended myocardium. To overcome this limitation, adjunctive diagnostic tools for functional evaluation, such as FFR, CFR, IMR and D-SPECT, have been introduced. In non-CTO patients, physiology-guided revascularization strategy has been definitely proven to be better than angiography-guided strategy in pivotal landmark studies. However, the clinical value of these functional parameters for the PCI of CTO is still unknown. The aim of this study was to determine whether functional evaluation is a better predictor of clinical outcome in patients with CTO undergoing PCI.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 and ≤80
  • Patients diagnosed with CTO by coronary angiography
  • Patient planned to receive PCI
  • Diameter of CTO vessel > 2.25 mm

Exclusion criteria

  • Age >80 or <18
  • Myocardial infarction with 1 months
  • Inability to give informed consent

Trial contacts and locations

0

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Central trial contact

Junbo Ge, MD

Data sourced from clinicaltrials.gov

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